Kornimate/medical-research-clean huggingface dataset:
static magnetic therapy for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: the purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for cts.


Eligibility criteria:
inclusion criteria: * diagnosis of mild to moderate carpal tunnel syndrome by history, clinical exam and electromyography (emg) study. * ≥ 18 years exclusion criteria: * current use of magnets as therapy for carpal tunnel syndrome * known allergy to silicone * unwillingness to wear wristband for 6 weeks * patients who have devices that may be affected by exposure to magnets such as vagal nerve stimulator, pacemaker or insulin pump.

Keywords: carpal tunnel syndrome
dual algorithm post market clinical study

Conditions: HTLV-I Infections; HTLV-II Infections; Human T-lymphotropic Virus 1; Human T-lymphotropic Virus 2; HTLV I Associated T Cell Leukemia Lymphoma; HTLV I Associated Myelopathies

Summary: the purpose of this study is to assess the validity and reproducibility of the mp diagnostics htlv blot 2.4 in blood specimens testing repeat reactive (rr) on the first fda licensed screening assay (abbott prism) and non-reactive (nr) on the second fda licensed screening assay (avioq elisa).

this is a prospective study designed to assess the safety and effectiveness of a dual algorithm testing for htlv i/ii in blood donors. the study hypothesis is that blood donors testing repeat reactive (rr) on the first fda licensed htlv screening assay and non-reactive (nr) on a second fda licensed screening assay will be confirmed as indeterminate or negative on the mp diagnostics htlv blot 2.4.

Eligibility criteria:
inclusion criteria: 1. male or female 2. completion of a health history evaluation for routine donor screening 3. provided a routine blood donation 4. tests repeat reactive by the abbott prism htlv assay and non-reactive on the avioq elisa htlv assay exclusion criteria: 1. unwilling or unable to provide informed consent to blood donation 2. inadequate sample volume for testing 3. unable to provide samples that meet the suitability requirements for testing

Keywords: htlv confirmatory supplemental blot htlv-i htlv-ii
injectable platelet rich fibrin with demineralized freeze-dried bone allograft in treatment of intraosseous defects

Conditions: Intrabony Periodontal Defect

Summary: clinical and radiographic evaluation of injectable platelet rich fibrin (i-prf) and demineralized freeze-dried bone allograft (dfdba) compared to demineralized freeze-dried bone allograft (dfdba) alone in management of intraosseous defects in stage iii periodontitis patients.

intraosseous defects are defined by the apical location of the periodontal pocket to the alveolar crest. in a recent radiographic study employing cone-beam computed tomography, a high prevalence of intraosseous defects 83% has been reported. treatment of intraosseous defects is clinically challenging, as they often require complex regenerative periodontal therapy. current regenerative techniques often employed in treatment of intraosseous defects demonstrate variation in improvement of clinical outcomes and degree of periodontal regeneration achieved.

Eligibility criteria:
inclusion criteria: 1. type iii periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intraosseous defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level ≥ 5 mm and pocket depth ≥ 6 mm. 2. defect not extending to a root furcation area 3. vital teeth 4. non-smokers. 5. no history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months. 6. no periodontal therapy carried out in the past 6 months. 7. able to sign an informed consent form. 8. patients age between 25 and 50 years old. 9. patients who are cooperative, motivated, and hygiene conscious. 10. systemically free according to cornell medical index exclusion criteria: 1. pregnancy or breast feeding 2. the presence of an orthodontic appliance 3. teeth mobility greater than grade i

Keywords: injectable platelet rich fibrin i-prf demineralized freeze-dried bone allograft dfdba stage 3 periodontitis 3 wall intraosseous defect 2 wall intraosseous defect
trial of endostar combined with chopt for t cell lymphoma

Conditions: T Cell Lymphoma

Summary: to evaluate the efficacy and safety of endostar combined with chopt in the treatment of t cell lymphoma.


Eligibility criteria:
inclusion criteria: 1. male and female aged 18 to 70 years old. 2. diagnosis of t cell lymphoma according to who classification, without antitumor therapy 3. at least 1 measurable tumor mass (greater than 1.5cm in the longest dimension and greater than 1.0 in the short axis) 4. eastern cooperative oncology group status 0-2 5. white blood cell≥4.0×109cells/l; absolute neutrophil count (anc) ≥1.5×109cells /l; platelets≥100×109cells/l 6. alanine transaminase (alt) ≤2×upper limit of normal(uln); aspartate transaminase (ast) ≤2×uln; total bilirubin≤1.5×uln; creatinine in normal range exclusion criteria: 1. no active central nervous system lymphoma or brain tumor 2. suppurative inflammation,chronic infection 3. severe heart disease, conclusion: congestive heart failure; uncontrolled cardiac arrhythmia; myocardial infarction; refractory hypertension 4. psychiatric history 5. primary cutaneous t cell lymphoma 6. pregnant or lactating women 7. concurrent treatment with another investigational agent 8. accept radiotherapy
a study assessing the pk, pd, safety, and tolerability of sb414 in psoriasis

Conditions: Psoriasis

Summary: the objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of sb414 in subjects with mild to moderate plaque psoriasis.

this is a phase 1b, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 36 adult subjects with mild to moderate chronic plaque psoriasis. after obtaining informed consent, subjects will be randomized to active or vehicle treatment arms. subjects will apply the study product (sb414 6% or vehicle cream) twice daily to all affected areas of psoriasis on the trunk and/or extremities for 4 weeks.

Eligibility criteria:
inclusion criteria: * be male or female, 18-70 years old, and in good general health; * have a clinical diagnosis of stable chronic plaque psoriasis of mild to moderate severity based on the psga, involving 2-15% bsa (excluding the scalp/face), present for \> 6 months; * must have at least 2 target plaques on trunk and/or extremities at least 5 cm2 with a tpss \> 5 and thickness sub-score \> 2. target plaques cannot be located on the groin, hands, feet, neck, face, elbows, knees, ankles or scalp; * be willing to not use any other systemic agents used to treat psoriasis or apply any other topical products (medicated or over-the-counter) to the treatment sites on the trunk and/or extremities during the study; * women of childbearing potential (wocbp) must have a negative upt prior to randomization and must agree to use an effective method of birth control during the study and for 30 days after their final study visit. exclusion criteria: * have inverse (i.e.: axillae, groin) or facial psoriasis only, erythrodermic psoriasis, guttate psoriasis, pustular psoriasis, drug-induced psoriasis, and /or psoriatic arthritis requiring treatment with disease modifying antirheumatic drugs (dmards); * concurrent or recent use of topical or systemic medications without a sufficient washout period; * are immunocompromised, including those who are known hiv positive or received immunosuppressive treatment within the past 6 months; * female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study.
development and application of portable multisensory stimulation device

Conditions: Cognitive Impairment

Summary: this is a study to develop the vibroacustic devices, and to compare the effects between vibroacustic device therapy and music therapy in adults with dementia or with neck pain. the immediate effect and long-term training effect would be assessed.

the outcome measures included functional assessment ( such as: range of motion, balance etc.) and neurolphysiological assessment (such as: electroencephalographic activity or electromyographic activity).

Eligibility criteria:
inclusion criteria: * mild to moderate dementia * age-matched healthy subjects exclusion criteria: * can not follow order

Keywords: electromyographic activity neck pain electroencephalographic activity dementia
efficacy and safety study of tlc388 to advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the safety and efficacy of tlc388 (lipotecan) as a second line treatment in subjects with advanced hepatocellular carcinoma.

a phase ii, open-label, single-arm, two-stage, multicenter study to evaluate the efficacy and safety of lipotecan® monotherapy in patients with advanced hepatocellular carcinoma (hcc) and had failed sorafenib treatment due to sorafenib intolerance or radiographic progressive disease (pd). eligible patients received 40 mg/m2 of lipotecan®, given as a 30-minute (+3 minutes) intravenous infusion, on days 1, 8, and 15 of a 28-day cycle for maximum 6 cycles. inter-cycle and intra-cycle dose delays were allowed within 21 days of the scheduled date to be reduced to 35 mg/m2 and further to 30 mg/m2 if a treatment-related adverse event (trae) met the criteria for dose reduction. tumor response was assessed every 2 cycles until cycle 6, or at the early termination according to recist version 1.1 judged by site investigator. the favorable response of cr, pr or sd would be confirmed within 28-35 days. safety evaluations were conducted on a weekly basis from the day study treatment administered throughout each cycle.

Eligibility criteria:
inclusion criteria: * radiological diagnosis of hepatic tumor(s) by contrast-enhanced study * subjects with advanced hcc who are not eligible for surgical resection or loco-regional therapy. * subjects with sorafenib treatment failure due to sorafenib intolerance or radiographic pd (as per recist v1.1). prior sorafenib use should be ≥ 400 mg/day for at least 14 days. * eastern cooperative oncology group (ecog) performance status of ≤ 1 * child pugh score ≤ 6; * a life expectancy of at least 12 weeks or more exclusion criteria: * subjects who have received any systemic target therapy or systemic chemotherapy other than sorafenib for the treatment of hcc. * subjects who have received sorafenib within 2 weeks prior to the initiation of the treatment dose, or have any sorafenib-related toxicities not yet resolved to grade 1 or baseline. * subjects who have undergone liver transplantation surgery. * major surgery within 4 weeks prior to the initiation of the treatment dose (excluding implantation of the intravenous infusion device). percutaneous liver puncture within 2 weeks prior to the initiation of the treatment dose.
study in intensive care patients to investigate the clinical effect of repetitive orally inhaled doses of ap301 on alveolar liquid clearance in acute lung injury

Conditions: Acute Lung Injury

Summary: the purpose of this study is to assess the effect of orally inhaled ap301 on alveolar liquid clearance in ali (acute lung injury) patients with the purpose to assess the treatment associated changes of extravascular lung water (evlw) within 7 days of treatment.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * intubated and mechanically ventilated male and female patients of the intensive care units of the department of anesthesia, general intensive care and pain control * meets the criteria of ali (as defined by the american-european consensus conference on ali/ ards): * onset of ali within 48 hours * bilateral infiltrates seen on frontal chest radiograph * pcwp ≤ 18 mm hg or no clinical evidence of left atrial hypertension * pao2/ fio2 ratio ≤ 300 mm hg * evlw in picco® at screening ≥ 8 ml/pbw * meeting criteria for extensive hemodynamic monitoring according to investigators discretion * icu patients being mechanically ventilated and are stable in this condition for at least 8 hours * negative pregnancy test and adequate contraception in female patients of childbearing potential * informed consent: * for patients that are temporarily unable to consent (e.g. comatose patients) a subsequent informed consent has to be provided. exclusion criteria: * history of clinically relevant allergies or idiosyncrasies to ap301 or any other inactive ingredient(s) of the investigational product * brainstem death at screening * current evidence of septic shock as defined by the surviving sepsis campaign (presence of acute organ dysfunction secondary to infection plus hypotension with systolic blood pressure \< 90 mm hg or mean arterial pressure (map) \< 70 mm hg for not less than one hour which cannot be reversed with fluid resuscitation) * neutrophil count \<0.3 x 109 l * patients under immunosuppression: high dose steroids (\> 80 mg prednisolone /d; \> 300 mg hydrocortisone / d), cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks * bmi \ 35 * cardiogenic pulmonary edema diagnosed by echocardiography or pulmonary artery catheter * pregnancy / lactation or intention to fall pregnant during the time course of the study * women of childbearing potential as well as men of procreative capacity who are not using adequate contraception * participation in other interventional drug trials

Keywords: peptide
prehospital routage of acute stroke patients with suspected large vessel occlusion: mothership versus drip and ship

Conditions: Stroke

Summary: background: the outcome of ischemic stroke is related to the brain lesion volume and this volume of infarction is directly related to the time to reperfusion, which therefore depends on the time to initiation of therapy. acute ischemic stroke is treated medically with the administration of intravenous rtpa, but recent randomized controlled trials have shown the efficacy of mechanical thrombectomy and is now the new gold standard in ischemic stroke. this new therapeutic strategy has created two possibilities for pre-hospital decision-making: i/ transport the patient directly to the nearest stroke unit to receive alteplase and then if indicated perform a thrombectomy (drip and ship) or ii/ bypassing thrombolysis centres in favour of endovascular thrombectomy (mothership). objective: to compare cost/effectiveness of transfer to the closest local stroke centre or telemedicine hub to direct transfer to the comprehensive stroke cent(csc) in patients acute stroke with suspected large vessel occlusion. medical and economic expected impact: we hypothesize that direct transportation to csc is associated with better clinical outcome in case of acute ischaemic stroke due to intracranial large vessel occlusion. however, we have to demonstrate that this approach is not associated with time from onset harm in patients not eligible to mechanical thrombectomy.

design: multicenter, two-arm, prospective, open, blinded end-point (probe), randomized, clinical trial primary endpoint: incremental cost-utility ratio at 12 months. secondary endpoints: modified rankin scale and euroqol5d scale at 3 months. eligibility criteria: a call to the emergency medical assistance service, 18 years and older, severe acute stroke symptoms, transportation time from scene to the csc longer than time to go to the nearest stroke unit or telemedicine hub, transportation time from scene to the csc compatible with iv thrombolysis, known time from onset, race score (assessed by medical emergency technicians) ≥5. experimental arm: direct transportation to the csc. control arm: transfer to the closest local stroke centre or telemedicine hub. sample size: 800 patients, 400 for each arm.

Eligibility criteria:
inclusion criteria: * a call to the emergency medical assistance service; * age\> 18y, * known time of stroke onset; * transportation time from scene to the csc longer than time to go to the nearest stroke unit or telemedicine hub; * transportation time from scene to the csc compatible with iv thrombolysis; * known time from onset, race score ≥5. exclusion criteria: * transportation time from scene to the csc longer than time to go to the nearest stroke unit or telemedicine hub. * no ambulance available * bedridden patient

Keywords: thrombectomy drip'n'ship versus mothership cost/effectiveness
glyburide and metformin for the treatment of gestational diabetes mellitus. systematic review

Conditions: Gestational Diabetes Mellitus

Summary: since the publication in the new england journal of medicine (nejm) in 2000 of the langer's trial comparing glyburide vs insulin in the treatment of gestational diabetes mellitus (gdm), additional studies of oral agents for the treatment of gdm have been published (observational, randomized controlled trials (rct), and trials using other drugs like metformin). some meta-analysis to summarize the evidence have been published: nicholson 2009 (including 4 rct addressing different drugs), dhulkotia 2010 (including 6 rct addressing different drugs, the meta-analysis combining all drugs altogether), gui 2013 (including 5 rct addressing metformin vs insulin). oral agents are increasingly used for the treatment of gdm. investigators aim to update the evidence on rcts comparing glyburide and metformin vs insulin or between them and summarize this evidence using meta-analysis tools. specifically, investigators aim at producing distinct meta-analyses for each one of the three drug comparisons. this information is not available in the literature since the most recent systematic reviews specifically dealing on oral agents for the treatment of gdm have addressed a single drug comparison (gui 2013) or have combined different drug comparisons into a single meta-analysis (dhulkotia 2010)

this project involves the systematic review of rct addressing the use of glyburide or metformin for the treatment of gdm. the review will include rct comparing these drugs versus insulin or making direct comparisons between the two oral agents in pregnant women with gdm. investigators have pre-specified a series of maternal and fetal outcomes of interest. a comprehensive electronic search strategy will be complemented with a search of bibliographies from relevant studies and the contact of authors from the eligible studies regarding issues on study design or information on primary outcomes. the risk of bias of included studies will be analyzed and this information used to perform sensitivity analyses. if possible, data from original studies will be pooled into relative risks for dichotomous outcomes and mean differences for continuous outcomes. heterogeneity will be explored for all the analyses. analyses will be undertaken using a fixed effects model that will be repeated using a random effects model in case of substantial heterogeneity. results of the systematic review will be published following prisma guidance.

Eligibility criteria:
inclusion criteria: * rct * gdm * comparing glyburide vs insulin, metformin vs insulin or metformin vs glyburide * data on fetal and/or maternal outcomes * full text available exclusion criteria: * significant overlap with other articles of the same group

Keywords: gestational diabetes mellitus glyburide metformin oral agents insulin outcomes
efficacy of adjusted clopidogrel dose in patients with insufficient platelet inhibition

Conditions: Coronary Artery Disease; Drug Resistance

Summary: this study is a prospective, single-center evaluation of the efficacy of clopidogrel dose adjustment in patients with insufficient platelet inhibition after elective coronary stent implantation.

background: the excelsior trial demonstrated a 7-fold increased risk for death, myocardial infarction and target vessel reintervention within 30 days in patients with platelet inhibition below median of study cohort after a bolus dose of 600 mg of clopidogrel. the median of platelet inhibition in this cohort was 14 % optical aggregation after stimulation with 5 µm adp. aim: to evaluate the efficacy of clopidogrel dose adjustment in patients with insufficient platelet inhibition after elective coronary stent implantation methods: this prospective, single-center study will evaluate antiplatelet effects in 120 patients receiving a bolus dose of 600 mg of clopidogrel before undergoing elective coronary stent implantation. platelet inhibition will be evaluated 24 hours, 14 and 28 days after coronary intervention using optical aggregometry (5 µm adp) and determination of surface protein expression by flow cytometry (p-selectin, gp55, activated gp iib/iiia). if 24 hours after coronary stent implantation optical aggregation is \>14 %, patients will receive an additional bolus dose of 300 mg of clopidogrel, followed by a daily dose of 150 mg for at least 28 days. if optical aggregation at this point of time is ≤14 % patients will receive a daily dose of 75 mg of clopidogrel. no further dose adjustments during follow up will be performed. hypothesis: adjustment of clopidogrel dose in patients with insufficient platelet inhibition determined by optical aggregometry will provide a comparable antiplatelet effect as in patients with sufficient platelet inhibition after coronary stent implantation.

Eligibility criteria:
inclusion criteria: * patients undergoing elective coronary stenting * pretreatment with a bolus dose of 600mg of clopidogrel at least 2 hours prior to coronary stent implantation * pretreatment with aspirin ≥ 100 mg per day for at least 7 days * age \> 18 years * written consent exclusion criteria: * troponin t on admission \> 0.03 ng/ml * myocardial infarction or fibrinolytic therapy within the previous 14 days * cardiogenic shock * contraindication for aspirin or clopidogrel * oral anticoagulation * pretreatment with heparin or a thienopyridine within the previous 14 days * use of a gp iib/iiia-receptor antagonist during pci * platelet count \< 100.000/µl * severe disorders of the coagulation system * severe impairment of liver or kidney function * cancer

Keywords: clopidogrel coronary artery disease dose-response relationship, drug drug resistance pci
validation of low dose ct for diagnosis of urolithiasis

Conditions: Nephrolithiasis; Ureterolithiases

Summary: the investigators have developed an extremely low dose renal computed tomography (ct) protocol that on preliminary testing has an effective dose in the range of a single view abdominal radiograph. the investigators plan to test this exam in patients with known or suspected urolithiasis undergoing clinically indicated ct.


Eligibility criteria:
inclusion criteria: * pediatric and young adult patients (ages 4 to \<21 years) * known or suspected urolithiasis * undergoing clinically indicated ct of the abdomen/pelvis exclusion criteria: * pregnancy * prior enrollment in the same study (no patient will be enrolled more than once)

Keywords: kidney stone renal renal stone